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510(k) K863775

RK VACUUM FIXATION RING SYSTEM by Ameritek, Inc. — Product Code HNH

K863775 is an FDA 510(k) premarket notification submitted by Ameritek, Inc. for the device "RK VACUUM FIXATION RING SYSTEM". The FDA issued a decision of Substantially Equivalent on October 20, 1986. The device falls under product code HNH (Ring, Ophthalmic (Flieringa)), a Class I device regulated under 21 CFR 886.4350. Ameritek, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1986
Date Received
September 26, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ring, Ophthalmic (Flieringa)
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Ameritek, Inc.

  • K001215 — DBEST HCG 2 IU/ML TEST KIT (June 22, 2000)
  • K990873 — DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE (September 1, 1999)
  • K990681 — DBSET MULTIDRUG SCREEN TEST KIT (July 15, 1999)
  • K984269 — DBEST OCCULT BLOOD TEST KIT (May 11, 1999)
  • K983189 — DBEST METHAMPHETAMINES TEST KIT (November 18, 1998)
  • K983190 — DBEST OPIATES TEST KIT (November 18, 1998)
  • K983188 — DBEST TETRAHYDROCANNABINOL TEST KIT (November 18, 1998)
  • K983191 — DBEST COCAINE TEST KIT (November 18, 1998)
  • K981504 — DBEST AMPHETAMINES TEST KIT (August 6, 1998)
  • K974508 — DBEST ONE-STEP OVULATION TEST (February 2, 1998)

Other clearances for product code HNH

  • K912269 — LANDERS NOTCHED IRRIGATING VITRECTOMY LENS RING (August 7, 1991)
  • K912268 — LANDERS NOTCHED VITRECTOMY LENS RING (August 7, 1991)
  • K912151 — LANDERS THREE STRUT VITRECTOMY LENS RING (July 25, 1991)
  • K902496 — LANDERS VITRECTOMY LENS RING W/INFUSION (July 24, 1990)
  • K850991 — LANDERS VITRECTOMY LENS RING SYSTEMS (March 29, 1985)
  • K832912 — GELENDER VACUUM FIXATION RING SYS (January 10, 1984)

FDA data resources